Premier Value
Calcium Polycarbophil
Pharmacy Value Alliance, Llc
Human Otc Drug
NDC 68016-220Premier Value also known as Calcium Polycarbophil is a human otc drug labeled by 'Pharmacy Value Alliance, Llc'. National Drug Code (NDC) number for Premier Value is 68016-220. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Premier Value drug includes Calcium Polycarbophil - 625 mg/1 . The currest status of Premier Value drug is Active.
Drug Information:
| Drug NDC: | 68016-220 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Premier Value |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Calcium Polycarbophil |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pharmacy Value Alliance, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CALCIUM POLYCARBOPHIL - 625 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 16 Apr, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part334 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | PHARMACY VALUE ALLIANCE, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 308934
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0840986015397
|
| UPC stands for Universal Product Code. |
| UNII: | 8F049NKY49
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68016-220-25 | 250 TABLET, FILM COATED in 1 BOTTLE (68016-220-25) | 16 Apr, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose bulk-forming laxative
Product Elements:
Premier value calcium polycarbophil calcium polycarbophil polycarbophil calcium carbonate caramel crospovidone (120 .mu.m) hypromellose, unspecified magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol, unspecified silicon dioxide sodium lauryl sulfate rp120
Indications and Usage:
Uses ? relieves occasional constipation to help restore and maintain regularity ? this product generally produces bowel movement in 12 to 72 hours
Warnings:
Choking warning: taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. do not take this product if you have difficulty in swallowing. if you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. ask a doctor before use if you have ? abdominal pain, nausea, or vomiting ? a sudden change in bowel habits that persists over a period of 2 weeks ask your doctor or pharmacist before use if you are taking any other drug. take this product 2 or more hours before or after other drugs. all laxatives may affect how other drugs work. when using this product ? do not use for more than 7 days unless directed by a doctor ? do not take more than 8 tablets in a 24 hour period unless directed by a doctor stop use and ask a doctor if rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. these could be signs o
Read more...f a serious condition. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.
When Using:
When using this product ? do not use for more than 7 days unless directed by a doctor ? do not take more than 8 tablets in a 24 hour period unless directed by a doctor
Dosage and Administration:
Directions ? take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. taking this product without enough liquid may cause choking. (see choking warning). ? this product works naturally so continued use for one to three days is normally required to provide full benefit. dosage may vary according to diet, exercise, previous laxative use or severity of constipation. age recommended daily maximum adults & children 12 years of age and over 2 caplets once a day up to 4 times a day children under 12 years consult a physician
Stop Use:
Stop use and ask a doctor if rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. these could be signs of a serious condition.
Overdosage:
In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.
Package Label Principal Display Panel:
Principal display panel ndc# 68016-220-25 premier value ® compare to the active ingredients fibercon ® caplets* fiber caplets calcium polycarbophil 625 mg bulk-forming fiber laxative gentle relief of constipation wont cause gas or bloating effective as fiber powders 250 caplets if for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. distributed by: pharmacy value alliance, llc 407 east lancaster avenue, wayne, pa 19087 *this product is not manufactured or distributed by pfizer inc., owner of the registered trademark fibercon® caplets premier value fiber caplets 250 counts
Further Questions:
Questions or comments? 1-866-467-2748